VALIDATION STANDARDS
onboard and want to achieve new levels of digital maturity.
The health secretary’s ‘tech vision’3 policy
paper sets the scene for building a digital architecture based on open standards, secure identity and interoperability, so that innovation can be adopted faster.
Dealing with larger numbers of IT systems
As new innovations become available and installed, the number of clinical IT systems used at each provider organisation increases - just look at the influx of new apps and advances in emerging technologies. Software is released more regularly, and open source technology has surged in popularity too. It is surprising how many people I speak to who are not aware that many clinical IT systems are classified as medical devices. This means everything from electronic patient record (EPR) systems, picture archiving communications technology, clinical messaging apps, video appointment software and wearables which are subject to guidelines by regulatory bodies such as MHRA, UKAS and CQC. All of these require a high level of validation to address clinical safety concerns and adhere to the medical device digital standards for clinical risk management (DCB0129) and clinical system deployment (DCB0160).
Competing internal agendas
My fear is that there are so many competing priorities and pressures when working on digital transformation that not enough time, focus and preparation is afforded to ensuring that systems meet the highest level of scrutiny for safety. We could end up compromising the very thing digital technology looks to help improve - patient safety.
It is not uncommon for local political pressure to influence the timing of a system going live, especially for a large EPR system. Shortcutting validation on new (first-of-their- kind) systems presents a huge risk because they have never been used anywhere else before.
In my experience these things are not driven from the bottom up, but from the top down, and the pressures are not associated with quality and safety, they are to do with expedience and, sometimes, the kudos of having a live system on time.
Lack of time or resources
The upshot is that the validation process is not given the due time, resources and quality to be delivered properly. The level of validation at the testing stages of the project is often not up to a standard that the regulators are seeking. If IT systems are launched into a live clinical environment, and if any discrepancies are then identified, the project team has to reactively address issues that that were not exposed through thorough testing.
Sometimes, and quite alarmingly, the people doing the validation are not necessarily
A fit-for-purpose IT system can free up more time for clinicians to spend with patients.
qualified or experienced to perform the task and have been seconded from another role to pick it up. CSV is often seen as a ‘low level’ checkbox exercise and given the potential risk to patient harm. This perspective needs to change.
No voice for clinicians
There’s no doubt we have come a long way in bridging the gap between IT and clinicians, and the introduction of the chief clinical information officer has had a huge impact in engaging with the clinical community, previously the fiercest resisters to change and new IT. The 2016 Wachter Review made the case for better usability, stating that “poorly designed and implemented systems can create opportunities for errors, and can result in frustrated healthcare professionals and patients,” adding that IT systems “must be designed with the input of end- users, employing basic principles of user-centered design.”4
There is also widespread acknowledgement that the lack of interoperable IT systems is severely holding clinicians back from working safely and efficiently. The rhetoric is being backed by investment through the continuation of the Global Digital Exemplar and Local Health and Care Record Exemplar programmes, which both place interoperability at its core. On a granular level, I still hear complaints from the clinical community when new technology is introduced, and their concerns have not been addressed. I can emphathise.
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WWW.CLINICALSERVICESJOURNAL.COM
There has been a long history of clinicians struggling to get to grips with technology because it does not add the desired value to their daily working lives.
While the debate over which technology is best for clinical end users remains open, the one certainty is that all clinicians have a vented interest in clinical IT systems working well. This is why they are passionately engaged in validating IT systems to ensure the quality standards are maintained.
Risks of non-validation
Healthcare providers who are unable to prove a clinical IT system does what it was intended to, through lack of validation, can face serious consequences. The most severe is causing direct patient harm. The MHRA is becoming more willing to take action against services that are not compliant with Blood Safety and Quality Regulations. In the most severe cases, this could mean the closure of any hospital services associated with blood transfusions.
If you get shut down, you will not be able
to perform routine operations, run maternity services, handle elective service or admissions. It would be a very high-profile public disaster and a major risk for any hospital provider in the country. It is therefore surprising that, given the risk, some NHS Trusts view validation as a lower resource requirement and often task junior members of staff with completing it. The MHRA will now only give a few days’ notice for an inspection, so departments such as
AUGUST 2019
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